(107 days)
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.
This document describes the safety and effectiveness of the Medinov-AMP Twist-off™ Screw (K971069).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum torque at rupture for separation of holder and screw | Averages 0.17 Nm |
| Maximum torque at rupture of the Twist-off™ Screw | Averages 0.37 Nm |
Note: The document does not explicitly state "acceptance criteria" through specific threshold values or ranges. Instead, it reports the average performance values obtained from testing. The implication is that these reported values were deemed acceptable for market clearance.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text, only "Testing of the Twist-off Screw was performed for the K962233." This indicates that tests were conducted, but the number of screw units tested is not specified.
- Data Provenance: Not specified. The manufacturer (Medinov-AMP) is located in Roanne, France, but the location where the testing was performed is not mentioned. The data is retrospective as the testing was completed prior to the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for this device's performance relies on physical testing of mechanical properties (torque at rupture), not on expert opinion or interpretation of images/data.
4. Adjudication Method for Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving subjective interpretation (e.g., image reading by multiple experts). The testing performed here involved objective mechanical measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret images or data, and the device aims to assist or replace human performance. The Twist-off™ Screw is a physical implant, not a diagnostic or AI-driven device.
6. Standalone Performance Study
Yes, a standalone study was performed in the sense that the mechanical properties of the device (torque at rupture) were tested independently. The reported values (0.17 Nm and 0.37 Nm) are the standalone performance of the screw under specific test conditions. This is a direct measurement of the device's physical capabilities, not an algorithm's performance.
7. Type of Ground Truth Used
The ground truth used was physical mechanical measurement. Specifically, the torque required to induce rupture, both for the separation of the holder and for the screw itself, was directly measured during testing.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical implant, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a mechanical implant device.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | Medinov-AMP27 à 31 rue Lucien Langenieux42335 Roanne FRANCE | |
|---|---|---|
| ESTABLISHMENT REGISTRATIONNUMBER (Manufacturer): | 9681744 | JUL - 9 1997 |
| SPONSOR IDENTIFICATION: | Cheryl HastingsDePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46580 | |
| ESTABLISHMENT REGISTRATIONNUMBER (Sponsor): | 1818910 | |
| PROPRIETARY NAME: | Twist-off tm Screw | |
| PRODUCT CLASSIFICATION CODE: | 87HWC | |
| PROPOSED REGULATORY CLASS: | Class II |
DESCRIPTION:
The Twist off Screw is made of titanium alloy and consists of a screw integrated with separates from the screw when the head meets cortical bone. It is 2.0mm in diameter and 11 to 14mm in length and has a selftapping tip.
INDICATIONS AND INTENDED USE:
This screw is to be implanted for the fixation of fracture, fusion of a joint or bone reconstruction of the carpals, metacarpals and phalanges of the hand.
PREDICATE DEVICES:
The predicate devices for this screw are the Landos Twist-off" Screw, the Howmedica Lubr Screw System, the Synthes Cortex Screw and the Osteomed M3 Screw.
TESTING:
Testing of the Twist-off Screw was performed for the K962233. The maximum torque at rupture for the separation of the holder and the screw averages 0.17Nm and the maximum lorque for rupture of the Twist-off Screw averages 0.37Nm.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, services, and the well-being of the American people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUM. SERVICES USA" in a circular arrangement.
JUL - 9 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings ·DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re : K971069 Twist-off™ Screw Requlatory Class: II Product Code: HWC May 30, 1997 Dated: Received: June 2, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act .
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) Class III devices are required to have an approved of the Act. premarket approval (FMA) application prior to marketing. Accordingly:
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this
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device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket
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Page 3 - Cheryl Hastings
notification" (21 CFR 807.97). Other general information on nocrited. (a) order the Act may be obtained from the your responsibiliti Division of Omari Nanaracourt (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
-
cole
-
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K971069 |
|---|---|
| Device Name: | Twist-off Screw |
| Indications for Use: |
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices, 1971069
510(k) Number.
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.